Esomeprazole for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs

Condition(s) targeted: NSAIDs; Upper GI Symptoms

Intervention: Esomeprazole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Nexium Medical Sciences Director, MD, Study Director, Affiliation: AstraZeneca

This study was a randomised, double-blind, parallel-group and placebo controlled study comparing the efficacy of esomeprazole 40 mg orally qd vs placebo and esomeprazole 20 mg orally qd vs placebo when given to patients on continuous use of NSAIDs, including COX-2 selective NSAIDs, for a treatment period of 4 weeks for relief of upper GI symptoms.

Official title: Efficacy of Esomeprazole 40 Mg Once Daily Versus Placebo and Esomeprazole 20 Mg Once Daily Versus Placebo in Treatment for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs Including COX-2 Selective NSAIDs

Study design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study

Primary outcome:

Mean change in the upper GI symptoms (pain, discomfort or

burning in the upper abdomen), rated on a 7-graded severity scale

Secondary outcome:

- Mean change in the upper GI symptom score

- The proportion of days with an upper GI symptom score of ‘None’ at 2 and 4 weeks of treatment.

- Mean upper GI symptom score by day over the duration of the study.

- Cumulative proportion of patients who achieve relief of upper GI symptoms by Week 2 and Week 4.

- Proportions of patients with upper GI symptoms during night, over the duration of the study.

- The proportion of patients with resolution or relief of investigator-recorded symptoms of heartburn, acid regurgitation, nausea & upper abdominal bloating at the 2-week, and 4-week visits.

- The mean change in the three dimensions Reflux, Abdominal pain and Indigestion of the Gastrointestinal Symptom Rating Scale (GSRS)

- Mean change in the three dimensions Emotional distress, Sleep disturbance and Food/Drink problems

- Patient’s global evaluation of relief of upper GI symptom (Overall Treatment Evaluation, OTE) at the 2-week, and 4-week visits.

-Short Form-36 (SF-36) score at baseline.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Signed informed consent.

- 18 years of age, or older.

- Capable of completing the diary card.

- Ability to complete the HRQL questionnaires.

- A clinical diagnosis of a chronic condition (e. g., osteoarthritis or rheumatoid

arthritis) that requires continuous daily NSAID treatment for at least 7 months. Daily NSAID treatment is defined as taking the prescribed dose for at least 5 of 7 days in any given week and can include COX-2 selective NSAIDs, multiple NSAIDs, and high-dose aspirin (>325 mg/day).

- Daily NSAID treatment dose and type: (Must have been stable for at least 4 weeks

prior to baseline endoscopy and; Are expected to remain stable for the duration of the study. and; Must be administered orally for the duration of the study. If more than one type of NSAID treatment is used, at least one type must be given orally.)

- Hp negative by UBT, serology or biopsy based test, at visit 1.

Exclusion Criteria:

- Current, or history of, gastric or duodenal ulcer

- Current, or history of, esophageal, gastric or duodenal surgery.

- History of GERD, not associated with NSAID use.

- Pain, discomfort or burning in the upper abdomen precipitated by exercise or relieved

by defecation.

- Pain, discomfort or burning in the upper abdomen not associated with the use of

NSAIDs, including COX-2 selective NSAIDs, as judged by the investigator.

- Endoscopic Barrett’s esophagus(>3 cm) or significant dysplastic changes in the

esophagus.

Research Site, Quesnel, Canada

Research Site, St. John's, Canada

Research Site, Quebec, Canada

Research Site, Ostrava, Czech Republic

Research Site, Praha-2, Czech Republic

Research Site, Praha 5, Czech Republic

Research Site, Verona, Italy

Research Site, Napoli, Italy

Research Site, Bærum postterminal, Norway

Research Site, Bergen, Norway

Research Site, Bodø, Norway

Research Site, Gjøvik, Norway

Research Site, Horten, Norway

Research Site, Kristiansand S, Norway

Research Site, Lillehammer, Norway

Research Site, Nesttun, Norway

Research Site, Oslo, Norway

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Research Site, Bydgoszcz, Poland

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Research Site, Bratislava, Slovakia

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Research Site, Cape Town, South Africa

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Research Site, Bredbyn, Sweden

Sweden, GÄVLE, Sweden

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Research Site, Ashford, United Kingdom

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Research Site, Bradford upon Avon, United Kingdom

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Research Site, Coventry, United Kingdom

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Research Site, Leigh, United Kingdom

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Research Site, Princeton, New Jersey, United States

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Research Site, Five Dock, New South Wales, Australia

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Research Site, St. John's, Newfoundland and Labrador, Canada

Research Site, Charlotte, North Carolina, United States

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Research Site, Sherbrooke, Quebec, Canada

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Research Site, Jackson, Tennessee, United States

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Research Site, Vicenza, VI, Italy

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Starting date: December 2000
Last updated: December 7, 2005